Fidaxomicin’s therapeutic equivalence to Dificid is confirmed, but indications are not explicitly stated.

Bioequivalence and Therapeutic Indications

The FDA confirms therapeutic equivalence of Fidaxomicin Tablets to Dificid, the RLD for Clostridioides difficile infection (CDI). While the document assumes alignment with Dificid’s labeled indications (e.g., treatment of CDI), specific efficacy data, such as clinical cure rates or recurrence reduction, are not detailed. The approval relies on bioequivalence studies rather than de novo clinical trials. Prescribers should infer efficacy from the RLD’s established profile, pending post-marketing surveillance for generic-specific outcomes.